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Switch to INSTI + NNRTI
SWORD Study: Switch to DTG + RPV
Original article : Llibre JM. Lancet. 2018 ; 391:839-49
Dernière mise à jour : 07/05/2018

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

• A switch to a novel, once-daily 2 drug-regimen of DTG + RPV demonstrated high efficacy and was non-inferior to the continuation
  of a combined antiretroviral therapy in virologically suppressed
  HIV-1–infected adults
• The safety profiles of both DTG and RPV were consistent with their respective labels
• Switching to DTG + RPV had a neutral effect on lipids, while significantly improving bone turnover biomarkers

Design

Endpoint

• Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (ITT-exposed, snapshot) ; non-inferiority if lower margin of a two-sided 95% CI for the difference = - 8% for pooled studies (- 10% for each individual study)

Baseline characteristics and patient disposition

Virologic outcome at W48 (ITT-E, snapshot)

Other virologic results at W48

• HIV RNA < 50 c/mL (ITT-E snapshot)
  • SWORD-1
    • 95% DTG + RPV
    • 96% continuation cART
    • Adjusted ≠: - 0.6% (95% CI: - 4.3 to + 3.0)
  • SWORD-2
    • 94% DTG + RPV
    • 94% continuation cART
    • Adjusted ≠: 0.2% (95% CI: - 3.9 to + 4.2)
• Confirmed virologic failure: HIV RNA ≥ 50 c/mL, retest ≥ 200 c/mL
• DTG + RPV, N = 2
  • Emergence of NNRTI resistance mutation (K101K/E) ‒
• Continued cART , N = 2
  • No mutations

HIV RNA of subject with NNRTI- resistant mutation

• 41-year-old female
  • Pre- cART HIV RNA > 2 millions c/mL ; 1 st cART : TDF/FTC/EFV
  • Randomised to DTG + RPV
  • Documented non-adherence before W36

HIV RNA, c/mL

Adverse events , %

* (some participants have more than 1 AE) ; anxiety (N = 4), depression (N = 3), insomnia (N = 2), depressed mood (N = 1), headache (N = 1), panic attack (N = 1), suicidal ideation (N = 1), tremor (N = 1), drug-induced liver injury (N = 1), eosinophilic pneumonia, acute (N = 1), abdominal distension (N = 2), dyspepsia (N = 2), peptic ulcer (N = 1), gastrointestinal haemorrhage (N = 1), pancreatitis, acute (N = 1), Hodgkin's disease (N = 1), Kaposi sarcoma (N = 1), plasmablastic lymphoma (N = 1)

Fasting lipids at baseline and W48

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